<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20190103042219N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-02</date_registration>
      <primary_sponsor>Central Tehran Branch, Islamic Azad University</primary_sponsor>
      <public_title>Phoneix Dactylifera pollen and delayed-onset muscle soreness indices</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Phoenix Dactylifera pollen supplementation on eccentric resistance exercise-induced delayed-onset muscle soreness in female athletes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-13</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47211</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Computerization was performed using a computer and a simple randomization method. The method used by the computer was that the computer selects random numbers between 0 and 1. Values less than 0.33 in the control group and values between 0.33 and 0.66 in the first intervention group (100 mg dose supplement) and values greater than 0.66 were in the second intervention group (200 mg dose supplement). Thus, 36 subjects were randomly divided into three groups, Blinding description: The participants were identified using the codes instead of their actual names. 
A third party was asked to classify the participants randomly, using the (labelled) codes. 
Study groups had codes instead of names. 
The laboratory was uninformed from name of groups and only used the codes. 
Groups codes were used for statistical analysis. 
The supplement and placebo participants were unaware of their own group label.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Delayed-onset muscle soreness.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Phoneix Dactylifera pollen (100mg). Participants consumed the  100 mg Phoneix Dactylifera pollen supplement for 10 days (one capsule a day). Phoenix dactylifera pollen powder purchased from the agriculture ministry and extracted. Intervention 2: Intervention group 2: Phoneix Dactylifera pollen (200mg). Participants consumed the  200 mg Phoneix Dactylifera pollen supplement for 10 days (one capsule a day). Phoenix dactylifera pollen powder purchased from the agriculture ministry and extracted. Intervention 3: Control group: Starch (200mg). Participants in this group received 200 mg of starch for 10 days as placebo (1 capsule per day).</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mohammad Ali Azarbayjani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Central Tehran Branch, Islamic Azad University, Sohanak Neighborhood, Artesh Highway, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1955847781</zip>
        <telephone>+98 21 2248 1622</telephone>
        <email>m_azarbayjani@iauctb.ac.ir</email>
        <affiliation>Central Tehran Branch, Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohammad Ali Azarbayjani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Central Tehran Branch, Islamic Azad University, Sohanak Neighborhood, Artesh Highway, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1955847781</zip>
        <telephone>+98 21 2248 1622</telephone>
        <email>m_azarbayjani@iauctb.ac.ir</email>
        <affiliation>Central Tehran Branch, Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Gender: Women
Athlete
Present in the Department of Physical Education, Central Tehran Branch, Islamic Azad Univirsity
Age limitation (22-26 years old)</inclusion_criteria>
      <agemin>22 years</agemin>
      <agemax>26 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having chronic or acute disease
Use of tobacco products
Alcohol consumption
Recent surgery or illness
Use of any medicine or dietary supplements</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G71</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Primary disorders of muscles</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Phoneix Dactylifera pollen (100mg). Participants consumed the  100 mg Phoneix Dactylifera pollen supplement for 10 days (one capsule a day). Phoenix dactylifera pollen powder purchased from the agriculture ministry and extracted.</i_keyword>
      <i_keyword>Intervention group 2: Phoneix Dactylifera pollen (200mg). Participants consumed the  200 mg Phoneix Dactylifera pollen supplement for 10 days (one capsule a day). Phoenix dactylifera pollen powder purchased from the agriculture ministry and extracted.</i_keyword>
      <i_keyword>Control group: Starch (200mg). Participants in this group received 200 mg of starch for 10 days as placebo (1 capsule per day).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Lactate dehydrogenase. Timepoint: Before exercise, 1,2,3 and 4 days after exercise. Method of measurement: ELISA Kit.</prim_outcome>
      <prim_outcome>Creatine kinase. Timepoint: Before exercise, 1,2,3 and 4 days after exercise. Method of measurement: ELISA Kit.</prim_outcome>
      <prim_outcome>Alanine aminotransferase. Timepoint: Before exercise, 1,2,3 and 4 days after exercise. Method of measurement: ELISA Kit.</prim_outcome>
      <prim_outcome>Aspartate aminotransferase. Timepoint: Before exercise, 1,2,3 and 4 days after exercise. Method of measurement: ELISA Kit.</prim_outcome>
      <prim_outcome>Lymphocytes. Timepoint: Before exercise, 1,2,3 and 4 days after exercise. Method of measurement: ELISA Kit.</prim_outcome>
      <prim_outcome>Neutrophils. Timepoint: Before exercise, 1,2,3 and 4 days after exercise. Method of measurement: ELISA Kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Angel of leg extension. Timepoint: Before exercise, 1,2,3 and 4 days after exercise. Method of measurement: Goniometer.</sec_outcome>
      <sec_outcome>Thigh circumference. Timepoint: Before exercise, 1,2,3 and 4 days after exercise. Method of measurement: Meter.</sec_outcome>
      <sec_outcome>Sargent jumping. Timepoint: Before exercise, 1,2,3 and 4 days after exercise. Method of measurement: Sargent test.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Central Tehran Branch, Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-12</approval_date>
        <contact_name>Ethic committee of Islamic Azad University, Gachsaran Branch</contact_name>
        <contact_address>Gachsaran Branch. Islamic Azad University, Modarress Street, Gachsaran, Kohgiluyeh and Boyer-Ahmad Province, Iran. Gachsaran Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
